NAUTILUS: OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

May 11, 2022

Primary Completion Date

January 29, 2025

Study Completion Date

January 29, 2025

Conditions
RAS MutationNRAS Gene MutationMelanoma
Interventions
DRUG

OKI-179 + binimetinib

"Phase 1b: With a 3+3 dose escalation design, enrollment in Phase 1b will proceed until the MTD has been defined or the highest dose level has been reached. OKI-179 will be administered on a 4-days-on/3-days-off schedule, while binimetinib will be administered BID continuously.~Phase 2: Patients will be treated with the RP2D."

Trial Locations (12)

10065

Memorial Sloan-Kettering Cancer Center, New York

22908

University of Virginia Health System, Charlottesville

30265

CTCA Atlanta, part of City of Hope, Newnan

30322

Emory University Winship Cancer Institute, Atlanta

32610

University of Florida Health Cancer Center, Gainesville

37203

Sarah Cannon Research Institute, Nashville

48202

Henry Ford Health System, Detroit

60099

CTCA Chicago, part of City of Hope, Zion

77030

University of Texas MD Anderson Cancer Center, Houston

85027

CTCA Phoenix, part of City of Hope, Phoenix

94143

University of California, San Francisco, San Francisco

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

OnKure, Inc.

INDUSTRY